Cyberkinetics Announces First Quarter Results.FOXBOROUGH, Mass. -- 510(k) Marketing Clearance for NeuroPort(TM) Neural Monitoring System Creates Path to Near-term Revenue Cyberkinetics Neurotechnology Systems, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). - CYKN) today announced financial results for the first quarter ended March 31 2005, and commented on highlights of the quarter and recent weeks. Clinical and Product Development Highlights --Obtained 510(k) marketing clearance for the NeuroPort(TM) Neural Monitoring System, Cyberkinetics' first clinical product. Limited market introduction is anticipated early in 2006. --Added Rehabilitation Institute of Chicago The Rehabilitation Institute of Chicago is a rehabilitation hospital located in Chicago, Illinois, United States. It is a part of the McGaw Medical Center of Northwestern University. as a recruiting site in the ongoing BrainGate(TM) pilot clinical trial. --Completed implantation implantation /im·plan·ta·tion/ (im?plan-ta´shun) 1. attachment of the blastocyst to the epithelial lining of the uterus, its penetration through the epithelium, and, in humans, its embedding in the stratum compactum of the of a second patient in the BrainGate trial. --Initiated clinical testing of key components of an automated interface for the BrainGate(TM) system. The automated interface is intended to make the BrainGate system less operator dependent and to provide patients with enhanced functionality by providing a standard interface to various types of personal digital assistant devices. --Completed successful initial bench testing of a complete wireless BrainGate system. The Alta program is designed to produce a wireless system which has no elements that pierce the skin, and will be both compact and unobtrusive. Financial Highlights --Secured a $3 million line of credit. --Generated 2005 first quarter revenue of $421,000, compared to $318,000 in the first quarter of 2004. "The first quarter of 2005 was marked by FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. market clearance of the NeuroPort(TM) System, which is labeled for temporary (less than 30 days) recording and monitoring of brain electrical activity. The NeuroPort is an innovative neural monitoring product that can be used by neurosurgeons and neurologists This is a list of the most important neurologists, with their dates of birth and death and nationality.
A condition that has its origin in some part of the patient's nervous system. Mentioned in: Pervasive Developmental Disorders ," said Chief Executive Officer Timothy R. Surgenor. "This approval gives us the opportunity to generate clinical revenue in early 2006. Response from neurosurgeons and neurologists to the NeuroPort System approval has been encouraging and we have begun to focus significant efforts on the planning for the launch of NeuroPort as well as on development of a distribution partnership for this important product." "During the quarter we continued to make progress on our product development and clinical goals in the BrainGate program," Surgenor said. "In particular, we are on track in our next generation software development program and will be able to provide future patients with the opportunity to participate in the testing and development of this automated interface. We believe the line of credit that we secured during the quarter, combined with our existing cash position, provides us with the flexibility to further develop our business." For the three months ended March 31, 2005, the net loss applicable to common stockholders was $2,247,000 or $0.14 per share based on 15,669,000 weighted average common shares outstanding, as compared to $1,310,000 or $0.32 per share for the three months ended March 31, 2004 based on 4,045,000 weighted average common shares outstanding. Weighted average common shares outstanding increased primarily due to the conversion of 9,419,000 shares of Series A Redeemable Redeemable Eligible for redemption under the terms of an indenture. Convertible Preferred Stock Convertible Preferred Stock Preferred stock that includes an option for the holder to convert the preferred shares into a fixed number of common shares, usually anytime after a predetermined date. Also known as "convertible preferred shares". in connection with the reverse merger in October 2004 as well as the issuance of 2,000,000 shares of common stock in connection with the private placement in November 2004. Financial results for the quarter ended March 31, 2005 are summarized in the table below. About Cyberkinetics Neurotechnology Systems, Inc. Cyberkinetics Neurotechnology Systems, a leader in brain-machine interface technology, is developing products to treat nervous system diseases and disorders by bringing together advances in neuroscience neu·ro·sci·ence n. Any of the sciences, such as neuroanatomy and neurobiology, that deal with the nervous system. neuroscience the embryology, anatomy, physiology, biochemistry and pharmacology of the nervous system. , computer science and engineering. Cyberkinetics' products are based on over ten years of technology development and cutting-edge neuroscience research at leading academic institutions such as Brown University, the Massachusetts Institute of Technology Massachusetts Institute of Technology, at Cambridge; coeducational; chartered 1861, opened 1865 in Boston, moved 1916. It has long been recognized as an outstanding technological institute and its Sloan School of Management has notable programs in business, , Emory University Emory University (ĕm`ərē), near Atlanta, Ga.; coeducational; United Methodist; chartered as Emory College 1836, opened 1837 at Oxford. It became Emory Univ. in 1915 and in 1919 moved to Atlanta. , and the University of Utah The University of Utah (also The U or the U of U or the UU), located in Salt Lake City, is the flagship public research university in the state of Utah, and one of 10 institutions that make up the Utah System of Higher Education. . Cyberkinetics is publicly traded on the Over the Counter Bulletin Board under the ticker symbol Ticker Symbol An arrangement of characters (usually letters) representing a particular security listed on an exchange or otherwise traded publicly. When a company issues securities to the public marketplace, it selects an available ticker symbol for its securities which investors CYKN. The Company is headquartered in Foxborough, Massachusetts Foxborough (or Foxboro) is a town in Norfolk County, Massachusetts, approximately 30 miles (48 km) southwest of Boston and 20 miles (32 km) northeast of Providence, Rhode Island. The population was 16,246 at the 2000 census. and conducts engineering and research in Salt Lake City, Utah For ships of the United States Navy of the same name, see . Salt Lake City is the capital and the most populous city of the U.S. state of Utah. The name of the city is often shortened to Salt Lake, or its initials, S.L.C. . Cyberkinetics' flagship product A primary product of a company, which is typically why the company was founded and/or what made it well known. For example, MS-DOS, Windows and the Microsoft Office suite have been flagship products of Microsoft. CorelDRAW is a flagship product of Corel Corporation. , the BrainGate(TM) Neural Interface System, is designed to give severely paralyzed par·a·lyze tr.v. par·a·lyzed, par·a·lyz·ing, par·a·lyz·es 1. To affect with paralysis; cause to be paralytic. 2. To make unable to move or act: paralyzed by fear. individuals a long-term, direct brain-computer interface A brain-computer interface (BCI), sometimes called a direct neural interface or a brain-machine interface, is a direct communication pathway between a human or animal brain (or brain cell culture) and an external device. for the purpose of communication and control of a computer and other devices. Patients are currently being enrolled into a pilot clinical trial to test the BrainGate(TM) System's safety and effectiveness. Cyberkinetics has received FDA clearance to market the NeuroPort(TM) System, a neural monitor designed for acute inpatient inpatient /in·pa·tient/ (in´pa-shent) a patient who comes to a hospital or other health care facility for diagnosis or treatment that requires an overnight stay. in·pa·tient n. applications and labeled for temporary (less than 30 days) recording and monitoring of brain electrical activity. The NeuroPort System can contribute to the diagnosis and treatment of neurological conditions in patients who have undergone craniotomy Craniotomy Definition Surgical removal of part of the skull to expose the brain. Purpose A craniotomy is the most commonly performed surgery for brain tumor removal. by providing neurologists and neurosurgeons a new resource to detect, transmit and analyze neural activity. Additional information is available at www.cyberkineticsinc.com. Forward Looking Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. Statement This announcement contains forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. , including statements about Cyberkinetics' product development plans and progress, financial status and commercial prospects. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995, and can be identified by the use of forward-looking terminology such as "may," "will," "believe," "expect," "anticipate" or other comparable terminology. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected in forward-looking statements and reported results shall not be considered an indication of our future performance. Factors that might cause or contribute to such differences include our limited operating history; our lack of profits from operations; our ability to successfully develop and commercialize our proposed products; a lengthy approval process and the uncertainty of FDA and other governmental regulatory requirements Regulatory requirements are part of the process of drug discovery and drug development. Regulatory requirements describe what is necessary for a new drug to be approved for marketing in any particular country. ; clinical trials may fail to demonstrate the safety and effectiveness of our products; the degree and nature of our competition; our ability to employ and retain qualified employees; compliance with recent legislation regarding corporate governance Corporate Governance The relationship between all the stakeholders in a company. This includes the shareholders, directors, and management of a company, as defined by the corporate charter, bylaws, formal policy, and rule of law. , including the Sarbanes-Oxley Act See SOX. of 2002; as well as those risks more fully discussed in our public filings with the Securities and Exchange Commission, all of which are difficult to predict and some of which are beyond our control
Cyberkinetics Neurotechnology Systems, Inc.
(A Development-Stage Company)
Condensed Consolidated Statements of Operations
(Unaudited)
Three Months Ended
March 31,
-----------------------
2005 2004
----------- -----------
Revenues:
Product sales $ 249,492 $ 128,682
Grant income 171,798 189,163
----------- -----------
Total revenues 421,290 317,845
Operating expenses:
Cost of product sales 44,656 82,230
Research and development 1,453,623 629,830
Sales and marketing 82,492 71,107
General and administrative 1,087,030 642,572
----------- -----------
Total operating expenses 2,667,801 1,425,739
----------- -----------
Operating loss (2,246,511) (1,107,894)
Other income
(expense)
Interest income 15,331 13,045
Interest expense (16,193) (6,647)
----------- -----------
Other income (expense), net (862) 6,398
Net loss $(2,247,373)$(1,101,496)
Dividends and accretion to redemption value
of redeemable convertible preferred stock - (208,383)
----------- -----------
Net loss attributable to common stockholders $(2,247,373)$(1,309,879)
=========== ===========
Basic and diluted net loss attributable to
common stockholders per common share $ (0.14)$ (0.32)
=========== ===========
Shares used in computing basic and diluted net
loss attributable to common stockholders per
common share 15,669,077 4,045,066
=========== ===========
Cyberkinetics Neurotechnology Systems, Inc.
(A Development-Stage Company)
Condensed Consolidated Balance Sheets
(Unaudited)
As of
March 31, December 31,
2005 2004
------------- -------------
Assets
Current assets
Cash and cash equivalents $ 3,728,812 $ 5,232,641
Other current assets 660,026 726,664
Net property and equipment 585,413 549,927
Other assets 256,492 246,871
------------- -------------
Total assets $ 5,230,743 $ 6,756,103
============= =============
Liabilities and stockholders' equity
Current liabilities $ 1,518,385 $ 1,308,245
Long-term liabilities 315,516 365,528
Stockholders' equity:
Common stock, $0.001 par value 16,981 16,939
Additional paid-in capital 19,490,501 17,835,622
Common stock held in escrow (13,000) (13,000)
Deferred stock-based compensation (1,178,481) (85,445)
Accumulated deficit (14,919,159) (12,671,786)
------------- -------------
Total stockholders' equity 3,396,842 5,082,330
------------- -------------
Total liabilities and stockholders'
equity $ 5,230,743 $ 6,756,103
============= =============
|
|
Printer friendly
Cite/link
Email
Feedback
Reader Opinion